MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

Event Description

The autopulse platform (sn (b)(6)) was deployed to resuscitate a cardiac arrest patient.During compressions, the autopulse platform displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message.The customer tried to clear the ua by rotating the driveshaft to the home position but could not rotate it.The crew immediately reverted to manual cpr.No consequences or impacts on the patient.

Manufacturer Narrative

The customer's complaint that the autopulse platform (sn (b)(6)) displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message was confirmed during the functional testing and the archive data review.The root cause of the ua45 advisory message was that the driveshaft was not in the "home" position, most likely attributed to unintended user error.Upon visual inspection, unrelated to the reported complaint, a crack across the screw well area of the front enclosure was noted.The observed physical damage is likely attributed to user mishandling, such as a drop.The front enclosure was replaced to address the observed physical damage.The archive data indicated several ua45 messages on the reported event date, confirming the reported complaint.The autopulse platform failed functional testing because the ua45 advisory message was displayed upon powering up, confirming the reported complaint.The driveshaft was rotated to the "home" position to remedy the ua45 advisory message.User advisory is a clearable message designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory (45), pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.Upon further inspection, the lcd's backlight was not functioning, unrelated to the reported complaint.The processor pca board was replaced to address the lcd issue.Subsequently, the autopulse platform successfully passed a 15-minute run-in test using the large resuscitation test fixture (lrtf).Following service, the autopulse platform passed the run-in and final tests without fault or error.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the autopulse platform with sn (b)(6).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18963637
• MDR Text Key: 338485377
• Report Number: 3010617000-2024-00239
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1